Major changes and implementation considerations of the 2024 version of the Declaration of Helsinki
10.12026/j.issn.1001-8565.2025.04.01
- VernacularTitle:2024年版《赫尔辛基宣言》的重大变化及实施思考
- Author:
Kexuan JIANG
1
;
Jiyin ZHOU
2
Author Information
1. Department of Medical Service， the 80th Group Army Hospital of the People’s Liberation Army of China， Weifang 261042， China
2. Clinical Medical Research Center， the Second Affiliated Hospital of Army Medical University， Chongqing 400037， China
- Publication Type:Journal Article
- Keywords:
Declaration of Helsinki;
research participant;
informed consent;
vulnerable group;
scientific integrity
- From:
Chinese Medical Ethics
2025;38(4):403-411
- CountryChina
- Language:Chinese
-
Abstract:
The World Medical Association approved the latest revision of the Declaration of Helsinki on October 19， 2024， which was revised again after 11 years. As the international ethical principles for medical research involving research participants worldwide， this revision aims to respond to the dynamic and rapidly changing research environment and to ensure its relevance. The main contents of this revision include changing subjects to research participants as partners； adding other researchers as the implementing subjects and requiring individuals， teams， and organizations to comply； adding social value， always for the purpose of improving individual and public health； requiring free and full informed consent and maintaining the autonomy of research participants； advocating fair distribution and encouraging community participation； responsibly integrating vulnerable individuals， groups and communities； supporting the maintenance of independent review and authority， and clarifying the dual ethical review of international collaborative research； strengthening the supervision of biological samples and data to prevent risks； emphasizing that the welfare of research participants should be continuously maintained after the end of the clinical trials； adding environmental sustainability and expanding the scope of attention； requiring scientific integrity and maintaining the research environment； demonstrating the scientific validity of research plans and avoiding research waste； adding ethical principles should be observed during public health emergencies； using placebos cautiously and avoiding abuse； clarifying the conditions for the use of unproven interventions. To implement the revised contents of the Declaration of Helsinki， measures that could be taken include applying to all human-related research to protect research participants； centering on patients to ensure that research meets patients’ needs； implementing responsible inclusion through the collaboration of all parties； strictly supervising biological samples and data to protect privacy and maintain sustainable and healthy development； strengthening the supervision of the use of unproven interventions to safeguard the long-term interests of patients； continuously constructing ethics committees and embracing the support of artificial intelligence； standardizing effective informed consent and implementing the principles of freedom and adequacy. The Declaration of Helsinki， which aims to promote and ensure respect and protection of participants in a rapidly innovating medical research ecosystem， will continue to face revisions brought about by new challenges in the future.
